Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Dentin Sensitivity
- Sponsor
- GlaxoSmithKline
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Schiff Sensitivity Score at Day 14
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Aged 18-65 years inclusive.
- •Good general and mental health with:
- •No clinically significant and relevant abnormalities of medical history or oral examination.
- •Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- •Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
- •Minimum of 20 natural teeth.
- •Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria at screening: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
- •Tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤
- •Tooth with signs of sensitivity measured by qualifying evaporative air assessment (yes\[Y\]/No\[N\] response).
Exclusion Criteria
- •Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Previous participation in this study or participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- •Recent history (within the last year) of alcohol or other substance abuse.
- •Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia.
- •Dental prophylaxis within 4 weeks of Screening.
- •Tongue or lip piercing or presence of dental implants.
- •Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
- •Teeth bleaching within 8 weeks of Screening.
- •Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
Outcomes
Primary Outcomes
Change From Baseline in Schiff Sensitivity Score at Day 14
Time Frame: Baseline, Day 14
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Secondary Outcomes
- Change From Baseline in Schiff Sensitivity Score at Day 7(Baseline, Day 7)
- Change From Baseline in Tactile Threshold at Day 7 and Day 14(Baseline, Day 7 and Day 14)